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Eurasian Economic Union
โ€ข Belarus, Kazakhstan, Kyrgyzstan, Russia
โ€ข Established 1 January 2015
โ€ข Fifth (sixth) economy in the world (according to different statistics)
โ€ข Estimated volume of the pharmaceutical market: USD 32 bn
โ€ข Seventh biggest pharmaceutical market in the world
โ€ข About 70% of the medicines are imported
โ€ข By 1 January 2016 โ€“ single pharmaceutical market
Sources: Sites of the Eurasian Economic Union and the Commission
The Common Principles for Medicines
โ€ข Agreement on the common principles and rules for turnover of
pharmaceuticals in the EAEU โ€“ already signed
โ€ข Includes pre- and clinical trials, registration, production, transport
across EAEU territory, import, quality control
โ€ข Requires a rapid legislation harmonization
โ€ข Unified registry for pharmaceuticals and electronic information
system
โ€ข Likely practical implications for national healthcare systems, including
in ARVs
Association Agreements with the EU
โ€ข Georgia, Moldova, Ukraine
โ€ข Pharmaceutical markets: Georgia - about 230 mln; Moldova - about
185 mln; Ukraine - about 2.7 bln.
โ€ข AA with FTAs concluded in 2014
โ€ข All refer to the need to use the TRIPS Agreement public health
flexibilities, as re-stated in the Doha Declaration to access medicines
โ€ข Also all include test data exclusivity
Data exclusivity requirements under AAs
Test data exclusivity
(no registration through
reliance)
Marketing exclusivity (can
register but cannot market)
Additional extensions
(new therapeutic
indications)
5
years
7
years
8
years
UNDP Analytical Report
โ€ข In 2015: analytical report on the
regulatory status of ARVs in CIS+
Georgia and Ukraine (patent,
registration, licensing, treatment
guidelines) with policy
recommendations. In Russian
and English.
โ€ข Synergy with BBPS analysis
โ€œTreating more for less in EECA",
which also covers some Western
Balkan countries.

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Eurasian Economic Union

  • 1. Eurasian Economic Union โ€ข Belarus, Kazakhstan, Kyrgyzstan, Russia โ€ข Established 1 January 2015 โ€ข Fifth (sixth) economy in the world (according to different statistics) โ€ข Estimated volume of the pharmaceutical market: USD 32 bn โ€ข Seventh biggest pharmaceutical market in the world โ€ข About 70% of the medicines are imported โ€ข By 1 January 2016 โ€“ single pharmaceutical market Sources: Sites of the Eurasian Economic Union and the Commission
  • 2. The Common Principles for Medicines โ€ข Agreement on the common principles and rules for turnover of pharmaceuticals in the EAEU โ€“ already signed โ€ข Includes pre- and clinical trials, registration, production, transport across EAEU territory, import, quality control โ€ข Requires a rapid legislation harmonization โ€ข Unified registry for pharmaceuticals and electronic information system โ€ข Likely practical implications for national healthcare systems, including in ARVs
  • 3. Association Agreements with the EU โ€ข Georgia, Moldova, Ukraine โ€ข Pharmaceutical markets: Georgia - about 230 mln; Moldova - about 185 mln; Ukraine - about 2.7 bln. โ€ข AA with FTAs concluded in 2014 โ€ข All refer to the need to use the TRIPS Agreement public health flexibilities, as re-stated in the Doha Declaration to access medicines โ€ข Also all include test data exclusivity
  • 4. Data exclusivity requirements under AAs Test data exclusivity (no registration through reliance) Marketing exclusivity (can register but cannot market) Additional extensions (new therapeutic indications) 5 years 7 years 8 years
  • 5. UNDP Analytical Report โ€ข In 2015: analytical report on the regulatory status of ARVs in CIS+ Georgia and Ukraine (patent, registration, licensing, treatment guidelines) with policy recommendations. In Russian and English. โ€ข Synergy with BBPS analysis โ€œTreating more for less in EECA", which also covers some Western Balkan countries.